Clinical trials are often required for getting a new drug approved by a regulatory agency like the FDA (Federal Drug Administration). The effect of a new therapeutic or diagnostic test on humans needs to be proven by following a clearly defined test procedure that is described in detail in a clinical trial protocol. After approval of the protocol by an ethics committee, a trial sponsor (e.g. a pharmaceutical company) recruits clinical sites and patients for the trial. Trial investigators are trained in how to conduct the trial according to the protocol. The necessary procedures (e.g., for administration of medication based on the new drug) are initiated and clinical data is generated, stored and validated according to the protocol description. Whereas some clinical data, e.g., a blood pressure value, can be easily checked, more complex data like images are difficult to handle. Protocol procedures involving image generation are more complex than for simple data such as a blood pressure measurement and require specially trained personnel. In a daily patient care routine the personnel often need to be innovative to find suitable image equipment parameters and processes to generate appropriate image quality to enable a radiologist to make qualified diagnostic decisions. Therefore the personnel are not used to following strict rules of a clinical trial protocol for image content assessment, for example.
If, as an example, a diameter of a tumor is relevant information describing whether a new drug is working or not, the diameter needs to be measured under repeatable conditions specified in a trial protocol, for example, using an image order as specified in the protocol. In known systems, there is no direct link between the image generation, quality assurance and image reading procedures and the trial protocol. A technician that generates the medical images and a radiologist that interprets the images need to be aware of constraints imposed by image generation, quality assurance and image reading procedures and trial protocol requirements. Further, following such procedures over long time periods (e.g., oncology trials typically last for 3-5 years) is a laborious and time consuming task in which errors are common. A system according to invention principles supports this process and reduces errors by addressing associated problems and deficiencies.